A Phase 1 Study to Evaluate the Relative Bioavailability of a VX-828 Tablet Formulation

Last updated: March 28, 2025
Sponsor: Vertex Pharmaceuticals Incorporated
Overall Status: Active - Recruiting

Phase

1

Condition

Cystic Fibrosis

Lung Disease

Treatment

VX-828

Clinical Study ID

NCT06861413
VX25-828-002
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purpose of this study is to evaluate the relative bioavailability of a VX-828 tablet formulation compared to a suspension and evaluate its safety and tolerability.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Body mass index (BMI) of 18.0 to 32.0 kilogram per square meter (kg/m^2)

  • A total body weight of more than (>) 50 Kg

  • Nonsmoker or ex-smoker for at least 3 months before screening

  • Participants of non-childbearing potential

Exclusion

Key Exclusion Criteria:

  • History of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug

  • Any condition possibly affecting drug absorption

Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 68
Treatment Group(s): 1
Primary Treatment: VX-828
Phase: 1
Study Start date:
April 01, 2025
Estimated Completion Date:
May 12, 2025

Study Description

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.)

Connect with a study center

  • Celerion - Tempe

    Tempe, Arizona 85283
    United States

    Active - Recruiting

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